Gastroparesis Registry 3

Completed

Conditions studied: Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis

In brief

The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.

Key facts

Study ID

NCT03680859

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

406

Starts

2019-01-24

Expected to finish

2024-05-13

Last updated by the study team

2024-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
• An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
• Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either:
• Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic gastric emptying study. (This group will comprise \~75% of patients in the registry.)
• Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise \~25% of patients in the registry.)
• Negative upper endoscopy or upper radiographic GI series within 2 years of registration
• Age at least 18 years at initial screening visit

You may not qualify if…

• Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
• Use of narcotic analgesics greater than three days per week
• Presence of other conditions that could explain the patient's symptoms:
• Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
• Active inflammatory bowel disease
• Known eosinophilic gastroenteritis or eosinophilic esophagitis
• Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
• Acute renal failure
• Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
• Acute liver failure
• Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
• Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior Nissen, Dor, or Toupet fundoplication will be eligible for enrollment.
• Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
• Inability to obtain informed consent

Where it is running

• University of Louisville — Louisville, Kentucky, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital-Digestive Healthcare Center — Boston, Massachusetts, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Texas Tech University Health Science Center (TTUHSC) — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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